6.ISO 80601-2-56{ed1.0}en文件

Reference numberISO 80601-2-56:2009(E)INTERNATIONAL STANDARD ISO80601-2-56First edition2009-10-01Medical electrical equipment —Part 2-56:Particular requirements for basic safetyand essential performance of clinicalthermometers for body temperaturemeasurementAppareils électromédicaux —Partie 2-56: Exigences particulières relatives à la sécurité fondamentaleet aux perfomances essentielles des thermomètres médicaux pour mesurer la température de corpsISO 80601-2-56:2009(E) PDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed butshall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. 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Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester.ISO copyright officeCase postale 56 • CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyright@Web Published in SwitzerlandISO 80601-2-56:2009(E)Contents PageForeword (v)Introduction (vi)201.1 * Scope, object and related standards (1)201.1. 1 Scope (1)201.1. 2 Object (2)201.1. 3 Collateral standards (2)201.1. 4 Particular standards (2)references (3)201.2 Normativeand definitions (3)201.3 Terminologyrequirements (6)201.4 General201.4. 2 R ISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS (6)201.4. 2.101 Additional requirements for RISK MANAGEMENT PROCESS for ME EQUIPMENT orME SYSTEMS (7)201.4. 3 E SSENTIAL PERFORMANCE (7)201.4. 3.101 * Additional requirements for ESSENTIAL PERFORMANCE (7)201.4. 101 Environmental conditions of use (7)201.5 General requirements for testing of ME EQUIPMENT (7)of201.6 ClassificationME EQUIPMENT and ME SYSTEMS (7)201.7 M E EQUIPMENT identification, marking and documents (7)201.7. 2.1 Minimum requirements for marking on ME EQUIPMENT and interchangeable parts (8)201.7. 2.1.101 Additional requirements for minimum requirements for marking on ME EQUIPMENT and interchangeable parts, marking of the packaging (8)201.7. 2.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (8)201.7. 2.101 Additional requirements for marking on the outside of ME EQUIPMENT orME EQUIPMENT parts (8)201.7. 4.3 Unit of measure (8)201.7. 4.3.101 Additional requirements for unit of measure (8)201.7. 9 A CCOMPANYING DOCUMENT (9)201.7. 9.1 Additional general requirements (9)201.7. 9.2 Additional requirements for instructions for use (9)201.7. 9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment,used material (9)201.7. 9.2.101 Instructions for use (9)201.7. 9.101 Additional requirements for ACCOMPANYING DOCUMENT (10)201.8 Protection against electrical HAZARDS from ME EQUIPMENT (10)mechanicalagainst201.9 ProtectionHAZARDS of ME EQUIPMENT and ME SYSTEMS (10)201.10 Protection against unwanted and excessive radiation HAZARD s (10)201.11 Protection against excessive temperatures and other HAZARDS (10)and instruments and protection against hazardous outputs (10)controlsof201.12 Accuracy201.12. 1 Accuracy of controls and instruments (10)201.12. 1.101 Additional requirements for accuracy of controls and instruments (10)201.12. 2 U SABILITY (11)201.12. 2.101 * Additional requirements for USABILITY (11)201.13 H AZARDOUS SITUATIONS and fault conditions (11)201.14 P ROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) (11)ISO 80601-2-56:2009(E)201.15 Construction of ME EQUIPMENT ................................................................................................11 201.16 M E SYSTEMS ...............................................................................................................................11 201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . (11)201.101 Laboratory performance requirements (11)201.101. 1 * General test requirements (11)201.101. 2 * Laboratory accuracy (12)201.101. 3 * Time response for a continuous clinical thermometer ........................................................13 201.102* Clinical accuracy validation.................................................................................................13 201.102. 1Method......................................................................................................................................13 201.102. 2* Human subject population requirements...........................................................................14 201.102. 3* Clinical bias calculation.......................................................................................................15 201.102. 4* Limits of agreement calculation..........................................................................................15 201.102. 5* Clinical repeatability calculation.........................................................................................16 201.103* Probes, probe cable extenders and probe covers............................................................16 201.103. 1General.....................................................................................................................................16 201.103. 2Labeling....................................................................................................................................17 202 Medical electrical equipment — Part 1-2: General requirements for basic safetyand essential performance — Collateral standard: Electromagneticcompatibility — Requirements and tests (17)202.6.2.1.10 Compliance criteria.................................................................................................................17 AnnexesAnnex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT andME SYSTEMS (19)Annex D (informative) Symbols on Marking (22)Annex AA (informative) Particular Guidance and rationale..........................................................................24 Annex BB (informative) R EFERENCE TEMPERATURE SOURCE .. (37)Annex CC (informative) Environmental aspects............................................................................................39 Annex DD (informative) Reference to the essential principles of safety and performance ofmedical devices in accordance with ISO/TR 16142 (40)Bibliography (42)Alphabetized index of defined terms used in this particular standard (45)ISO 80601-2-56:2009(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 80601-2-56 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in cooperation with Subcommittee 62D, Electrical equipment, of Technical Committee IEC/TC 62: Electrical equipment in medical practice.ISO 80601 consists of the following parts, under the general title Medical electrical equipment:⎯Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators⎯Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation⎯Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors⎯Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement⎯Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical useIEC 80601-2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers, IEC 80601-2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses intended for heating in medical use, IEC 80601-2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery, IEC 80601-2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening and IEC 80601-2-60: Particular requirements for basic safety and essential performance of dental equipment are published by IEC.ISO 80601-2-56:2009(E)IntroductionIn this International Standard, the following print types are used.⎯Requirements and definitions: roman type.⎯Test specifications: italic type.⎯Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type.⎯T ERMS DEFINED IN C LAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.In referring to the structure of this International Standard, the term⎯“clause” means one of the 20 numbered divisions within the table of contents, inclusive of all subdivisions(e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);⎯“subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7).References to clauses within this International Standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this International Standard are by number only.In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.The verbal forms used in this International Standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this International Standard, the auxiliary verb:⎯“shall” means that compliance with a requirement or a test is mandatory for compliance with this standard;⎯“should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard;⎯“may” is used to describe a permissible way to achieve compliance with a requirement or test.An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA.This international standard deals with electrical CLINICAL THERMOMETERS, either already available or that will come available in the future.The purpose of a CLINICAL THERMOMETER is to assess the true temperature of a REFERENCE BODY SITE. The temperature of the PATIENT'S body is an important vital sign in assessing overall health, typically in combination with blood pressure and pulse rate. Determining whether a PATIENT is afebrile or febrile is an important purpose of a CLINICAL THERMOMETER, since being febrile suggests that the PATIENT is ill.ISO 80601-2-56:2009(E) There are different temperatures at each REFERENCE BODY SITE according to the balance between the production, transfer, and loss of heat.[38]C LINICAL ACCURACY of a CLINICAL THERMOMETER is VERIFIED by comparing its OUTPUT TEMPERATURE with that of a REFERENCE THERMOMETER, which has a specified uncertainty for measuring true temperature. For an equilibrium CLINICAL THERMOMETER, the CLINICAL ACCURACY can be sufficiently determined under laboratory conditions that create an equilibrium state between the two thermometers.For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, laboratory VERIFICATION alone is not sufficient because the adjustment algorithm for deriving the OUTPUT TEMPERATURE includes the characteristics of the PATIENT and the environment.[3] Therefore the CLINICAL ACCURACY of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE has to be VALIDATED clinically, using statistical methods of comparing its OUTPUT TEMPERATURE with that of a REFERENCE CLINICAL THERMOMETER which has a specified CLINICAL ACCURACY in representing a particular REFERENCE BODY SITE temperature.For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, the LABORATORY ACCURACY is VERIFIED in a DIRECT MODE and the CLINICAL ACCURACY is VALIDATED in the ADJUSTED MODE(OPERATING MODE) with a sufficiently large group of human subjects.The intention of this International Standard is to specify the requirements and the test procedures for the VERIFICATION of the LABORATORY ACCURACY for all types of electrical CLINICAL THERMOMETERS as well as for the VALIDATION of the CLINICAL ACCURACY of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE.INTERNATIONAL STANDARD ISO 80601-2-56:2009(E)Medical electrical equipment —Part 2-56:Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement201.1 * Scope, object and related standardsIEC 60601-1:2005, Clause 1 applies, except as follows:201.1.1 ScopeReplacement:This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This standard specifies the general and technical requirements for electrical CLINICAL THERMOMETERS. This standard applies to all electrical CLINICAL THERMOMETERS that are used for measuring the body temperature of PATIENTS.C LINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME SYSTEMS. This standard does not apply to auxiliary equipment.M E EQUIPMENT that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of this standard.EXAMPLE 1 Swan-Ganz thermodilution determination of cardiac output is not in the scope of this standard. EXAMPLE 2 A Foley catheter that includes a temperature PROBE is in the scope of this standard.EXAMPLE 3 P ATIENT heating ME EQUIPMENT that includes a skin temperature measurement such as infant incubators, heating blankets, heating pads and heating mattresses are not in the scope of this standard, unless they indicate a temperature of a REFERENCE BODY SITE in which they are in the scope of this standard.Requirements for ME EQUIPMENT intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601-2-59:2008 and such ME EQUIPMENT is not covered by this standard.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.H AZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in IEC 60601-1:2005, 7.2.13 and 8.4.1.NOTE Additional information can be found in IEC 60601-1:2005, 4.2.ISO 80601-2-56:2009(E)201.1.2 ObjectReplacement:The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for a CLINICAL THERMOMETER, as defined in 201.3.206, and its ACCESSORIES.NOTE A CCESSORIES are included because the combination of the CLINICAL THERMOMETER and the ACCESSORIES needs to be safe. A CCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER.standards201.1.3 CollateralAddition:This particular standard refers to those applicable collateral standards that are listed in IEC 60601-1:2005, Clause 2, as well as Clause 2 of this particular standard.IEC 60601-1-3 does not apply.standards201.1.4 ParticularReplacement:In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.A requirement of a particular standard takes priority over IEC 60601-1.For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number.The numbering of sections, clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:“Replacement” means that the clause or subclause of the IEC 60601-1 or applicable collateral standard is replaced completely by the text of this particular standard.“Addition” means that the text of this particular standard is additional to the requirements of the IEC 60601-1 or applicable collateral standard.“Amendment” means that the clause or subclause of the IEC 60601-1 or applicable collateral standard is amended as indicated by the text of this particular standard.Subclauses or figures which are additional to those of the general standard are numbered starting from 201.101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 6060-1-3, etc.The term “this standard” is used to make reference to the IEC 60601-1, any applicable collateral standards and this particular standard taken together.ISO 80601-2-56:2009(E) Where there is no corresponding section, clause or subclause in this particular standard, the section, clause or subclause of the IEC 60601-1 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the IEC 60601-1 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.201.2 NormativereferencesNOTE Informative references are listed in the bibliography beginning on page 43.IEC 60601-1:2005, Clause 2 applies, except as follows:Replacement:IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic compatibility — Requirements and testsIEC 60601-1-6:2006, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral Standard: UsabilityIEC 60601-1-8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsAddition:ISO 14155-1:2003, Clinical investigation of medical devices for human subjects — Part 1: General requirementsISO 14155-2:2003, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plansISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsAmendment 1:2008IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performanceIEC 60601-1-9:2007, Medical electrical equipment — Part 1-9: General requirements for basic safety and essential performance — Collateral Standard: Requirements for environmentally conscious designIEC 60601-1-10:2007, Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral Standard: Requirements for the development of physiologic closed-loop controllers201.3 Terminology and definitionsFor the purposes of this document, the terms and definitions given in IEC 60601-1:2005, IEC 60601-1-6:2006, IEC 60601-1-8:2006, and the following definitions apply.NOTE An alphabetized index of defined terms is found beginning on page 45.Additions:201.3.201* ADJUSTED MODEOPERATING MODE where the OUTPUT TEMPERATURE is calculated by adjusting the signal from the input SENSOR。